Urinary incontinence is defined as the loss of bladder control permitting urine to inadvertently leak from the bladder. It has been estimated that up to 35% of noninstitutionalized elders are incontinent and greater than 50% of nursing home occupants are incontinent of urine.
Urinary incontinence is a costly medical problem both in health care costs and poor patient outcomes. Annually, millions of health dollars are spent to diagnose the causes of incontinence and to provide medical treatment either with medications, surgery and/or various known devices. Disposable underwear partially absorbs the urine and is commonly used to maintain some semblance of hygiene. In spite of the use of disposable underwear, clothes and bed linens require more frequent laundering as they are frequently soaked through wetting. Due to the incontinence, the patient's skin is frequently wet, in an acid environment, resulting in skin breakdown and its complications in bedridden and institutionalized individuals.
Frequently due to caregiver frustration with the effects of incontinence and the lack of a reliable urine external collection system, indwelling tubes are placed into the bladder (i.e. a foley catheter). These indwelling bladder catheters inevitably become colonized with bacteria causing frequent infections that are often life threatening in elderly or disabled patients.
Disposable diapers and briefs/underwear are the most common solution to urinary incontinence in the general population as well as hospitalized and institutionalized patients.
External male urine collection systems are infrequently used because the currently available systems are prone to detachment and wetting. These devices are generally ineffective and uncomfortable for the wearer. No external male urine collection system is sufficiently reliable to allow its use for multiple hours without falling off or becoming increasingly uncomfortable for the wearer.
The most common external collection device used (or attempted) for hospitalized patients is the external condom catheter, comprising a tube connected to an end of a condom collection unit that is attached to the penis with an adhesive or pressure band (i.e. commonly referred to as a “Texas catheter”). The collection unit rarely functions properly because the penis constantly changes size during the day and the condom collection assembly falls off, wasting caregiver time and institutional monies. A dry genital area cannot be maintained when the condom is displaced from its initial position and therefore leaks urine from the collection unit. Another approach maintains the condom collection unit in place with an elastic belt that fits around the patient's waist and/or legs. Force exerted by the elastic retains the collection unit in place.
A variation of the condom catheter is an adhesive unit that fits around only a tip of the penis, i.e. only around the glans penis. This collection assembly is directly connected to a collection bag and tubing to direct the fluid away from the patient. This approach is problematic for long term use because of the risk of skin breakdown with the daily use of an adhesive and the difficulty in maintaining adherence to the glans penis when the penis size contracts and the penis retracts.
Another urine collection approach comprises a custom brief further comprising a condom-like catheter disposed within a pocket formed in the brief. The urine exits the condom catheter into a collection bag. This unit is expensive and, like the other condom-type units described above, fails when the penis contracts.
Due to the various described disadvantages for the catheter-type urine collection systems, a disposable brief or underwear made from a non-woven material is therefore the most common approach for managing urinary incontinence, as well as fecal incontinence. However, in spite of its high absorbency properties the diaper or brief eventually becomes wet. Long periods in wet underwear cause skin breakdown and multiple other ensuing complications. There is therefore a need for a comfortable, reliable, disposable external urine collection system.